Alleviating Healthcare Disparities with Re-used Pacemakers

1. Alleviating Healthcare Disparities with Re-used Pacemakers Thomas Crawford, MD Assistant Professor of Medicine The University of Michigan

2. Global Cardiovascular Disease Mortality MendisS.J Hypertension. 25, 1578-1582

3. Overwhelming majority of deaths due to CVD occur in low and middle income countries 1 million people die annually from untreated brady-arrhythmia worldwide Cardiovascular Disease Burden Joshi RJ Am CollCardiol. 2008 Dec 2;52(23):1817-25.

4. Bradyarrhythmia Therapy Disparities Mond HG. PACE 2008 Sep;31(9):1202-12.

5. My Heart Your Heart – The Mission • Bridge the gap between the demand for pacemakers and their inadequate supply in the low and middle income countries • Create a blueprint for a safe and legal pacemaker reuse • Establish a non-profit with the goal of device acquisition, sterilization, and distribution to patients in need outside the U.S.

6. MHYH – Who Are We? • The University of Michigan Cardiovascular Center • Michigan Funeral Directors Association • World Medical Relief • Implant Recycling, Inc. • Patients and families nationwide

7. Making the Case for Device Reutilization • Preliminary Safety Data • Patient and General Population Views • Funeral Home Director Surveys • Feasibility of device acquisition • Pivotal clinical trial

8. Prior Studies of Pacemaker Reutilization • Medical databases searched for studies that examined pacemaker re-use (1970 to 2011) • 18 small studies have examined the safety of pacemaker re-use • Meta-analysis to compare complication rate of new vs. reused devices

9. Baman et al Circ-EP 2011

10. Pacemaker Meta-Analysis Reutilized pacemakers are not at higher risk of infection when compared to new device implant Baman et al Circ-EP 2011

11. Pacemaker Meta-Analysis Reutilized pacemakers are at a higher risk of device malfunction when compared to new device implantation Baman et al Circ-EP 2011

12. Patient and General Population Survey • 100 device patients • 1009 members of general population in U of M Clinics waiting rooms 87 <0.01 71 P=0.80 58 % In Favor 53 P=0.10 42 37 Gakenheimer et al JICE 2011 *Responses were not mutually exclusive

13. Funeral Director Survey Gakenheimer et al JICE 2011

14. Devices with Acceptable Batteries Adequate battery life defined as ≥75% remaining or ≥4 years longevity 320 (15%) 118 (18%) 112 (30%) 68% 21% 12%

15. Study Design • Prospective multicenter study of safety and efficacy • Standardized and validated sterilization protocol • 500 patients • Interim analysis at 12 months (complications). • Longevity analysis • Up to 7 years

16. Legal Counsel Food and Drug Administration • Authorize safe and legal device distribution • Provide consent and guidelines for distribution Funeral Homes & Crematories Center(s) of Excellence Non Profit Charitable Organization • Consent family and explant devices • Establish communication with funeral homes to facilitate device collection • Sterilize and package devices • Assess qualifications and safety record of implanting centers • Maintain database of all devices received and distributed Funeral Directors Association LMIC Device Implantation Center • Facilitate awareness and interaction between funeral homes and academic center • Assess financial status of possible recipients • Safely and effectively implant devices • Provide follow-up data for implanted devices

17. Conclusion • Prior studies support the safety of pacemaker re-use • General public, pacemaker patients, and funeral home directors support reutilization • Approximately 1 out of 5 devices have >75% original battery life • Establishing a validated pacemaker reuse program could transform a currently wasted resource into an opportunity for a new life

18. Date: Tuesday, September 4, 2012 9:59 AM Dear Sir/Madam:  My wife recently passed away (August 11, 2012) and one of her final wishes was that her pacemaker be donated for someone in need.At my request, our funeral director removed the device and I have the pacemaker, a Medtronic Sigma Sdr dual lead, at home. Our family would very much like to donate this device to a needy person overseas. Your attention to this matter will allow me to complete this final request.  Thank you, DJA

19. Letter to Project My Heart • “I am blessed to be helped by your humanitarian and godly efforts which gave me hope and life. Truly I have a happy life because you made me feel loved even though you didn’t know me.”

20. Thank you! • Sandra Arlinghaus, Ph.D. • Frank Arlinghaus, M.D. • John Nystuen , Ph.D. • Kim A Eagle, M.D. • TimirS Baman, M.D. • Patricia Sovitch, NP

21. Acknowledgements MHYH is supported by grants from: The Hewlett Foundation The Mardigian Foundation University of Michigan Cardiovascular Center Mr. Sheldon Davis The Sincock Family

22. www.myheartyourheart.org